October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations.

May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

The NIDCD is committed to identifying effective
interventions for the treatment or prevention of communication disorders by
supporting robust, well-designed, and well-executed clinical trials. This
funding opportunity announcement (FOA) supports a cooperative agreement
between NIDCD project collaborator and investigator to support phase I and II
clinical trials of preliminary efficacy and phase III clinical trials of
definitive efficacy. Phase III clinical trial applications must include a
complete detailed Manual of Procedures (MOP) in the appendix (see http://www.nidcd.nih.gov/research/clinicaltrials for an example of a complete, detailed MOP). The NIDCD Planning Grant for
Phase III Clinical Trials in Communication Disorders (U34) (PAR-12-124)
may be used to gather information and prepare the MOP.

Key Dates

Posted Date

March 16, 2012

Open Date (Earliest Submission Date)

May 4, 2012

Letter of Intent Due Date

30 days before planned submission date.

Application Due Date(s)

June 4, 2012; October 4, 2012; February 4, 2013; June
4, 2013; (Extended to November 1, 2013 per NOT-OD-14-003), Originally October 4, 2013,February 4, 2014; June 4, 2014; October 3, 2014; February 4, 2015 , by 5:00 PM local time of applicant
organization.

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide, except where instructed to do otherwise
(in this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

Phase I clinical trials test a new biomedical or behavioral intervention
in a small group of people for the first time to determine efficacy and
evaluate safety (e.g., determine a safe dosage range and identify side
effects), in anticipation of a phase II clinical trial of preliminary efficacy.
The phase I research application should directly address how the phase I study
will guide the development of subsequent phase II and III clinical trials.

Relevant
phase I research topics include, but are not limited to the following:

Determining the best methods for identifying and recruiting study
subjects

Phase II Clinical Trials

Phase II clinical trials study the biomedical or behavioral intervention in a
larger group of people to determine preliminary efficacy and further evaluate
safety, in anticipation of a phase III clinical trial of definitive efficacy. The
phase II clinical trial should collect and develop essential preliminary
information rather than simply address the clinical question with lower power,
i.e. a phase II trial should not simply be a miniature version of a phase III
trial.

Phase III clinical trials determine efficacy of the biomedical or behavioral
intervention in large groups of people by comparing the intervention to other
standard or experimental interventions as well as to monitor adverse effects,
and to collect information that will allow the interventions to be used safely.
Basic elements of the phase III clinical trial application are similar to those
of phase II clinical trials, described above. Also see Section V. Application
Review Information, Significance, Investigators and Approach.

Phase III clinical trial applications must include a
complete detailed Manual of Procedures (MOP) in the appendix (see http://www.nidcd.nih.gov/research/clinicaltrials for an example of a complete, detailed MOP). The NIDCD Planning Grant for Phase
III Clinical Trials in Communication Disorders (U34) (PAR-12-124) may be used to gather information and prepare
the MOP.

Each phase III definitive clinical trial must have a Study
Chair who is responsible for the overall development and conduct of the trial and
provides both the scientific and administrative leadership for the trial; a Clinical
Coordinating Center that provides overall coordination for the clinical trial to
ensure data quality, conformance to implementing the MOP, quality assurance,
statistical analyses, and assistance with preparing publications; a Data
Coordinating Center for design and implementation of data forms, and for data
entry, management and integrity; and Clinical Centers that are responsible for
implementing the protocol, recruiting patients, providing the
intervention/prevention required, conducting patient follow up, and submitting
data to the Data Coordinating Center.

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

Award Budget

Application budgets are not limited, but must reflect
actual needs of the proposed project. Because the nature and scope of the
proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plan of the NIDCD provides support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds. Facilities and Administrative (F&A) costs requested by consortium
participants are not included in the direct cost, see NOT-OD-05-004.

Award Project Period

Up to five years

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the applications
submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

If an NIDCD phase III clinical trial planning grant was
awarded, then the phase III clinical trial applicant should include in the
Preliminary Studies for New Applications section a brief summary of the
activities achieved during the planning period. Regardless of whether a
planning grant was used first, all phase III clinical trial applications must
have a complete, detailed Manual of Procedures (MOP) included as an Appendix
(see http://www.nidcd.nih.gov/research/clinicaltrials for an example of a complete, detailed MOP).

For phase III clinical trial applications, sections within
the MOP should describe details of the operations of the Study Chair, Clinical
Coordinating Center, Data Coordinating Center, and Clinical Centers. In
describing the different aspects of the phase III clinical trial in the body of
the application to address the review criteria (see Section V.1 Significance,
Investigators and Approach), the applicant should refer to appropriate sections
in the MOP to provide peer reviewers with complete details; however, all
required application pieces must be contained within the application proper. The
MOP should not be used to circumvent application page limits.

Single-site phase I and II clinical trial applications
should be submitted as one application.

Multi-site phase I and II clinical trial applications
should be submitted as two paired applications from the Study Chair/Clinical
Coordinating Center and the Data Coordinating Center. Individual Clinical
Centers should be subcontracts to the Study Chair/Clinical Coordinating Center.
This information must be clearly communicated to NIDCD prior to submission as
well as in a cover letter at the time of submission, to ensure correct
assignment by Division of Receipt and Referral.

All phase III clinical trial applications should be
submitted as two paired applications from the Study Chair/Clinical Coordinating
Center and the Data Coordinating Center. Individual Clinical Centers should be subcontracts
to the Study Chair/Clinical Coordinating Center. The MOP must be an Appendix to
the Study Chair/Clinical Coordinating Center application.

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct
costs requested for any one year, should address a Data Sharing Plan. The
NIDCD asks that all phase I, II and III clinical trials be registered in
ClinicalTrials.gov. The FDA requires that all phase II and III clinical trials
with IND or IDE be registered in ClinicalTrials.gov. Publications related to
the clinical trial must be published in NIH PubMed Central.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide. For this clinical trial Funding Opportunity Announcement,
the following documents may be submitted in the Appendix as necessary:

questionnaires

data collection instruments

clinical protocols

informed consent documents

Investigator Brochure for an Investigational Device Exemption
(IDE) or Investigational New Drug (IND)

In phase III clinical trial
applications, the above should be included directly in the MOP.

Foreign Institutions

Foreign (non-US) institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions
described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Applicants are strongly encouraged but are not required to
submit a clinical trial concept document to the NIDCD for programmatic review
prior to submitting an application in response to this FOA. For information on
the NIDCDs Clinical Trial Concept Procedure see Clinical Trials on NIDCDs
website at http://www.nidcd.nih.gov/research/clinicaltrials.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

In order to expedite review, applicants are requested to
notify the NIDCD Referral Office by email at stickm@nidcd.nih.gov when the
application has been submitted. Please include the FOA number and title, PD(s)/PI(s)
name, and title of the application.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before
submitting the application and follow the Policy on the Acceptance for Review
of Unsolicited Applications that Request $500,000 or More in Direct Costs as described
in the SF 424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Does the applicant address the following:

A clear statement of the questions(s) that the trial will address
and its importance;

Information adequate to determine the significance and timeliness
of as well as the need to perform the trial;

Preliminary data or the literature supporting the need for a
clinical trial to test the proposed hypothesis or intervention;

Reasons for selection of the intervention, study agent(s), and
mode of delivery including specific details such as dose or a particular
procedure; and,

The ethical issues surrounding the trial and the
disease/condition under study?

Investigators

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PDs/PIs, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Does the application describe the leadership and
proposed organization of the clinical trial PD(s)/PIs/Study Chair have the
experience to provide the leadership and management to the clinical trial
network? Do the clinical site PDs/PIs have experience in running a clinical
site and/or clinical trial experience and in successfully recruiting and
retaining patients in a research study? Does the Director of the Clinical
Coordinating Center have prior clinical trial experience and experience in
managing a coordinating center for a multicenter clinical trial? Does the Data
Coordinating Center have the appropriate expertise?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

For phase I and II clinical trials, how likely is it
that the proposed design will eventually lead to a phase III clinical trial?
What is the importance of the preliminary clinical trial to the eventual
success of the phase III definitive clinical trial? What is the importance of
the phase III clinical trial?

Is the experimental design adequate and does it
address the following (as applicable):

Translation of the clinical question into a statistical
hypothesis;

Primary and secondary outcome variable(s) and data to be
collected, including relevance to the clinical and statistical hypothesis being
tested;

Criteria for evaluating outcome variable(s);

Sample size and duration of the trial;

Randomization if needed, masking if appropriate, controls, and
inclusion/exclusion criteria;

Plans to standardize and monitor adherence to the clinical protocol;

Interim data monitoring if appropriate;

Plans to obtain any required study agent;

Methods for standardization of procedures for data management to
assess the effect of the intervention and quality control; and,

Appropriateness of the general statistical approach and specific
analytic techniques and plans for handling dropouts, missed visits, and losses
to follow up?

Does the application document the
following related to patient recruitment/retention (as applicable):

Is the safety monitoring plan
adequate and does it address the following:

Risks involved;

Ethical aspects of risks

Risk-benefit balance;

Informed consent procedures; and,

Provisions for early termination?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NIDCD, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center.
Applications will compete for available funds with all other recommended
applications.. Following initial peer review, recommended applications will
receive a second level of review by the appropriate national Advisory Council
or Board. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative
agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities. Consistent
with this concept, the dominant role and prime responsibility resides with the
awardees for the project as a whole, although specific tasks and activities may
be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

All aspects of the study, including any modification of study
design, conduct of the study quality control, data analysis and interpretation,
preparation of publications, dissemination of data, tools, and technologies,
and collaboration with other investigators. The awardee agrees to accept close
coordination, cooperation, and participation of NIDCD staff in those aspects of
scientific and technical management of the study as stated in these terms and
conditions commensurate with the degree of potential risk to study subjects and
the complexity of the study.

Upon
implementation of the protocol, each field center, whether a single institution
or a consortium of institutions, will follow the procedures required by the
protocol regarding study conduct and monitoring, patient management, data
collection, and quality control;

Managing
involvement of industry or any other third party in the study. Except for
licensing of patents or copyrights, support or involvement of any third party
will occur only following notification of and concurrence by the NIDCD; and

Making
all study materials and procedure manuals available in the public domain.
Awardees are expected to publish and publicly disseminate results, data, and
other products of the study, concordant with governance policies and protocols.
Publications and oral presentations of work performed under this agreement will
require appropriate acknowledgment of support by the NIDCD/NIH.

Awardees will retain custody of and have primary rights to the
data and software developed under these awards, subject to Government rights of
access consistent with current DHHS, PHS, and NIH policies.

NIH staff has substantial programmatic involvement that
is above and beyond the normal stewardship role in awards, as described below:

Have access to data generated under this Cooperative Agreement
and may periodically review the data and progress reports. NIDCD staff may use
information obtained from the data for the preparation of internal reports on
the activities of the study. However, awardees will retain custody of and have
primary rights to all data developed under these awards, subject to Government
rights of access consistent with HHS, PHS, and NIH policies;

Provide guidance and support in the development, assembly, and
submission of all required regulatory documents, e.g., those regarding the use
of investigational drugs, to the Food and Drug Administration;

Serve as a resource to provide scientific/programmatic support
during the accomplishment of the research by participating in the design of the
activities, advising in the selection of sources or resources (e.g.,
determining where a particular reagent can be found), provision of research
resources and reagents available from the NIDCD grantees and contractors,
advising in management and technical performance, or participating in the
preparation of publications;

Review the progress of the study, and of each participating
facility, through consideration of the annual reports, site visits, patient
logs, etc. This review may include, but is not limited to, compliance with the
study protocol, meeting patient enrollment targets, adherence to uniform data
collection procedures, and the timeliness and quality of data reporting;

Oversee the adequacy of adverse event management and reporting,
and have regular communications with the PD(s)/PI(s) and study team, which may
include attendance at the safety monitoring (or DSMB) and related committee
meetings;

Monitor progress of study milestones. At each scheduled interim
review, compare actual enrollment to the benchmarks and criteria identified in
the application and negotiated prior to award.

Studies in which recruitment milestones are not met as per
criteria established pre-award, or for which regulatory approval has not been
met within one year, and are deemed unlikely to improve sufficiently to bring
the study to completion within an acceptable budget or time frame, may be
closed for lack of progress following review and consideration by NIDCD staff.

If a study is finally determined to lack feasibility and
will no longer accrue subjects, awardees are required to submit a close-out
plan to NIDCD staff within three months of a decision either by NIDCD staff or
the grantee that an awarded study is no longer feasible. The plan must be
approved and signed by the Institutional Official and the PI/PD(s) listed on
the award prior to submission.

The NIDCD may terminate or curtail the study (or an
individual award) in the event of (a) failure to implement the study protocol,
(b) a substantial shortfall in participant recruitment, follow-up, data
reporting and dissemination, quality control, or other major breach of the
protocol, (c) substantive changes in the agreed-upon protocol with which the
NIDCD does not concur, (d) reaching a major study objective substantially
before schedule with persuasive statistical evidence, or (e) human subject
ethical issues that may dictate a premature termination.

Additionally, an agency program official or IC program
director will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice.

Areas
of Joint Responsibility include:

Data Safety and Monitoring Board: An independent Data and Safety
Monitoring Board will be established jointly by the PD(s)/PI(s) and NIDCD. The
Data and Safety Monitoring Board will review interim results periodically as
established in the data and safety monitoring plan and report to the NIDCD
Program Director. The NIDCD Program Director will report in writing to the PD(s)/PI(s)
on the recommendations of the DSMB and the NIDCD concurrence/non-concurrence of
the DSMB recommendations. The PD(s)/PI(s) will assume responsibility for
reporting of the DSMB and the NIDCD recommendations to their Institutional
Review Board.

Dispute
Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the PD(s)/PI(s), chosen without NIH staff voting, one NIH designee,
and a third designee with expertise in the relevant area who is chosen by the
other two; in the case of individual disagreement, the first member may be
chosen by the individual awardee. This special dispute resolution procedure
does not alter the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart
D and DHHS regulation 45 CFR Part 16.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006
(Transparency Act), includes a requirement for awardees of Federal grants to
report information about first-tier subawards and executive compensation under
Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Prior consultation from NIDCD is strongly encouraged for submission of the
NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01) grant
application, including new and resubmission applications. Staff will consider
whether the proposed clinical trial meets the goals and mission of the
Institute and whether it is appropriate to conduct it as an
investigator-initiated clinical trial. In the presubmission consultative
phase, if the proposed trial does not meet the goals and mission of NIDCD,
applicants will be strongly encouraged to look at other funding opportunities,
OR applicants will be informed that the proposed trial does not meet the goals
and mission of NIDCD.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.